Sr Quality Compliance Associate

Aldevron; Fargo (ND); On-site; USD 95,000 - 130,000; Full time

Benefits offered by this job

Benefits

Job summary

Aldevron seeks a Sr. Quality Compliance Associate - Quality Systems to lead complex quality system activities and provide advanced oversight in Fargo, ND. You will assess quality risks, resolve compliance issues, and strengthen regulatory readiness as a subject matter expert within the Quality Assurance team.

This on-site role collaborates across functions. You will review deviations, CAPAs, change controls, and quality records while driving improvements, metrics analysis, and risk-based

Qualifications

• Bachelor’s degree in biology, microbiology, chemistry, other life science field, or related discipline is required.
• 4+ years of Quality Assurance experience in regulated pharma/biotech/medical device.
• Advanced experience managing and reviewing quality system records (deviations, CAPAs, change controls).
• Experience leading cross-functional investigations, risk assessments, or compliance initiatives.
• Experience analyzing quality metrics and driving continuous improvement.

Responsibilities

• Lead review and approval of complex deviations, CAPAs, change controls and other quality system records to ensure regulatory compliance.
• Mentor and train quality system owners, reviewers, and cross-functional stakeholders as a SME for quality system requirements.
• Analyze quality system performance metrics, identify adverse trends, recommend corrective actions, and escalate significant compliance risks to Quality Management.
• Lead continuous improvement initiatives to enhance quality system effectiveness, inspection readiness, and site-wide compliance.
• Partner with operational, technical, and quality stakeholders on strategic projects, audits, client interactions, and regulatory inspections.

Skills

Quality Assurance

CAPA

Deviations

Change controls

Risk assessments

Cross-functional investigations

Regulatory compliance

Quality metrics

Education

Bachelor’s degree in biology, microbiology, chemistry, life science or related discipline

Job description

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

At Aldevron, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.

You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.

At Aldevron, we deliver world‑class CDMO services that accelerate the development of groundbreaking therapies. Our mission is to be the engine of innovation for genomic medicine pioneers. As a member of our team, you’ll help bring life‑changing innovations to life—impacting millions around the world. We bring together deep scientific expertise, an unwavering commitment to quality, and a collaborative spirit to drive progress. Whether you’re launching your career or bringing years of experience, we value the unique perspective you bring. Join us and become part of a mission‑driven team advancing science and unlocking human potential—one discovery at a time.

Learn about the Danaher Business System which makes everything possible.

The Sr. Quality Compliance Associate - Quality Systems leads complex quality system activities, provides advanced quality oversight, and drives continuous improvement across the site. This role serves as a subject matter expert who partners across functions to assess quality risks, resolve complex compliance issues, improve quality system performance, and strengthen regulatory readiness.

This position reports to the Sr. Manager, Quality Systems and is part of the Quality Assurance team located in Fargo, North Dakota. This role will be on site.

In This Role, You Will Have The Opportunity To

• Lead the review and approval of highly complex deviations, corrective and preventive actions (CAPAs), change controls, and other quality system records to ensure compliance with applicable regulations and internal requirements.
• Mentor and train quality system owners, reviewers, and cross‑functional stakeholders while serving as a subject matter expert for quality system requirements and best practices.
• Analyze quality system performance metrics, identify adverse trends, recommend corrective actions, and **escalate** significant compliance risks to Quality Management.
• Lead continuous improvement initiatives that enhance quality system effectiveness, inspection readiness, and site‑wide compliance performance.
• Partner with operational, technical, and quality stakeholders on strategic projects, audits, client interactions, and regulatory inspections.

The Essential Requirements Of The Job Include

• Bachelor’s degree in biology, microbiology, chemistry, another life science field, or a related discipline.
• 4 or more years of Quality Assurance experience in a regulated pharmaceutical, biotechnology, medical device, or related industry.
• Advanced experience managing and reviewing quality system records, including deviations, CAPAs, and change controls.
• Experience leading cross‑functional investigations, risk assessments, or compliance initiatives.
• Demonstrated experience analyzing quality metrics and driving continuous improvement activities.

It would be a plus if you also possess previous experience in:

• Biologics, cell and gene therapy, or pharmaceutical manufacturing environments.
• ASQ or RAPS certification.

• Aldevron, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.

Join our winning team today. Together, we’ll accelerate the real‑life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.

The U.S. EEO posters are available here.

For candidates who are based outside of New York City or who are applying for roles outside of New York City, for more information about conditions of any job offer please click here.

We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact:1-202-419-7762 or [e-mail].